Associate Director, Reliability Engineering

About the role

The Associate Director of Reliability Engineering is responsible for developing, leading, and continuously improving the site reliability program to maximize equipment uptime, shutdown RTS performance, asset performance, product quality, safety, and regulatory compliance within a pharmaceutical manufacturing environment.

Responsibilities

• Develop and execute the site's Reliability Engineering strategy aligned with business and operational goals.
• Improve and optimize manufacturing building shutdown program and vertical RTS (return to service) performance.
• Lead reliability improvement initiatives for manufacturing equipment, process systems, utilities, and critical facilities.
• Establish reliability standards, policies, procedures, and best practices across the organization.
• Lead and communicate reliability metrics data to site leadership.
• Serve as the subject matter expert for asset reliability and maintenance excellence.
• Develop and manage Reliability-Centered Maintenance (RCM) programs.
• Analyze equipment performance, failure trends, and maintenance effectiveness to improve reliability.
• Conduct root cause analysis (RCA), failure mode and effects analysis (FMEA), and risk assessments.
• Identify and implement solutions to reduce downtime and improve Overall Equipment Effectiveness (OEE).
• Establish asset criticality models and reliability KPIs.
• Partner with Maintenance and Operations teams to optimize preventive and predictive maintenance programs.
• Drive implementation and utilization of condition-based monitoring technologies, including: Vibration analysis, Infrared thermography, Oil analysis, Ultrasound monitoring, Motor circuit analysis.
• Support maintenance planning, scheduling, and work management processes within CMMS platforms.
• Maintain maintenance performance metrics and identify continuous improvement opportunities.
• Ensure reliability programs comply with cGMP, FDA, EMA, and applicable regulatory requirements.
• Support regulatory inspections, audits, and quality investigations.
• Collaborate with Quality Assurance and Validation teams to maintain validated states of equipment and systems.
• Participate in deviation investigations, CAPA development, and change control processes.
• Ensure data integrity, documentation accuracy, and adherence to quality standards.
• Provide reliability oversight for critical GMP systems, including: HVAC, Water for Injection (WFI), Clean Steam, Compressed Air, Building Management Systems (BMS).
• Support risk mitigation strategies for critical utility and facility assets.
• Lead initiatives to improve system availability and energy efficiency.
• Support design reviews and reliability requirements for new capital projects.
• Ensure maintainability and reliability principles are incorporated into equipment design and procurement.
• Develop asset replacement and lifecycle management strategies.
• Participate in FAT, SAT, commissioning, qualification, and startup activities.
• Utilize reliability and maintenance data to drive decision-making.
• Develop dashboards and reports to monitor reliability performance.
• Lead Lean, Six Sigma, and operational excellence initiatives.
• Benchmark reliability performance against industry best practices.
• Drive digital transformation initiatives related to smart maintenance and Industry 4.0 technologies.

Required qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline) required.
• Master's degree in Engineering, Business Administration, or related field preferred.
• 10+ years of engineering, maintenance, or reliability experience within the pharmaceutical, biotechnology, medical device, or highly regulated manufacturing industries.
• 5+ years of leadership experience managing technical teams.
• Demonstrated success implementing reliability and maintenance excellence programs in GMP-regulated environments.
• Experience supporting FDA, EMA, and regulatory inspections.
• Reliability-Centered Maintenance (RCM)
• Root Cause Analysis (RCA)
• FMEA and Risk-Based Maintenance
• CMMS systems (Maximo, D365, Blue Mountain, or similar)
• Predictive Maintenance technologies
• Asset Lifecycle Management
• OEE and Reliability Metrics
• GMP manufacturing operations
• Validation and Qualification processes
• Pharmaceutical utility systems

Preferred qualifications

• Certified Reliability Engineer (CRE)
• Certified Maintenance & Reliability Professional (CMRP)
• Lean Six Sigma Green Belt or Black Belt
• Project Management Professional (PMP)

Physical / safety requirements

• Ability to utilize required personal protective equipment (PPE)
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to stand or sit for extended periods of time